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FDA 510(k)

HealthPPT

K-Number: K211803 · 2021-12-15

Decision Date2021-12-15
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HealthPPT is the device name listed in this FDA 510(k) record. The listed applicant is Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K211803. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HealthPPT?

HealthPPT is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Zebra Medical Vision, Ltd.. The 510(k) number is K211803.

When did HealthPPT receive FDA 510(k) clearance?

HealthPPT received FDA 510(k) clearance on 2021-12-15, under 510(k) number K211803.

Who is the listed applicant for HealthPPT?

The FDA 510(k) record lists Zebra Medical Vision, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HealthPPT?

The FDA product code for HealthPPT is QFM.

Other records listing Zebra Medical Vision, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 9 devices →

Related Devices (Code: QFM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.